Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT07111195
Brief Summary:
The goal of this clinical trial is to validate ONCOhabitats, an advanced imaging software, as a medical device for the clinical management of IDH-wildtype glioblastoma.
The study aims to evaluate whether imaging biomarkers derived from pre-surgical MRI using ONCOhabitats can predict overall survival and support clinical decision-making.
The primary research questions are:
* Can ONCOhabitats identify vascular and molecular characteristics within the peritumoral infiltrated edema (IPE) that are associated with patient prognosis?
* Can these imaging biomarkers aid in stratifying patients according to their response to treatment, including temozolomide and immunotherapy?
Participants will:
* Be adults diagnosed with high-grade glioma who are scheduled for surgical tumor resection
* Undergo preoperative MRI processed with ONCOhabitats to segment the tumor into four biological habitats (HAT, LAT, IPE, and VPE)
* Provide tissue samples from each habitat when feasible, based on surgical and clinical considerations
Researchers will analyze:
* Imaging biomarkers (e.g., relative cerebral blood volume, rCBV)
* Molecular and histopathological features (e.g., MGMT promoter methylation, gene expression profiles associated with immunosuppression)
* Clinical and survival outcomes
This study seeks to enhance glioblastoma characterization and support personalized treatment strategies through the clinical validation of a software platform.
Study:
NCT07111195
Study Brief:
Protocol Section:
NCT07111195